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卡巴他赛可改善转移性前列腺癌患者多项临床指标
作者:小柯机器人 发布时间:2019/10/1 13:04:36

荷兰鹿特丹伊拉斯谟医疗中心Ronald de Wit小组比较了卡巴他赛与阿比特龙、恩扎鲁胺治疗转移性去势抵抗性前列腺癌的疗效。该研究2019年9月30日在线发表于《新英格兰医学杂志》。

与雄激素受体信号传导抑制剂相比,卡巴他赛治疗先前接受过多西紫杉醇和替代性抑制剂治疗无效的转移性去势抵抗性前列腺癌患者的疗效和安全性尚不清楚。

研究组招募了255名转移性去势抵抗性前列腺癌患者,先前均接受过多西紫杉醇和雄激素受体信号传导抑制剂治疗。将其按1:1随机分组,其中129名接受卡巴他赛治疗,每3周静脉注射一次,联合每日强的松和粒细胞集落刺激因子;126名接受雄激素受体信号传导抑制剂治疗,每天1000mg阿比特龙+强的松,或每天160mg恩扎鲁胺。

中位随访9.2个月后,卡巴他赛组中有95例(73.6%)患者出现影像学进展或死亡,而雄激素受体信号传导抑制剂组中有101例(80.2%),风险比为0.54。卡巴他赛组和雄激素受体信号传导抑制剂组的中位影像学无进展生存期分别为8.0个月和3.7个月,中位总生存期分别为13.6个月和11.0个月,死亡风险比为0.64,差异显著。

卡巴他赛组和雄激素受体信号传导抑制剂组的中位无进展生存期分别为4.4个月和2.7个月,前列腺特异性抗原反应率分别为35.7%和13.5%,肿瘤缓解率分别为36.5%和11.5%,差异均具有统计学意义。卡巴他赛组和雄激素受体信号传导抑制剂组中3级及以上不良事件的发生率分别为56.3%和52.4%,未发生新的安全事件。

综上,与雄激素受体信号传导抑制剂相比,对于先前接受过多西紫杉醇和替代性雄激素信号传导靶向药物治疗的转移性去势抵抗性前列腺癌患者,卡巴他赛可显著改善多项临床指标,值得推广。

附:英文原文

Title: Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer

Author: Ronald de Wit, Johann de Bono, Cora N. Sternberg, Karim Fizazi, Bertrand Tombal, Christian Wülfing, Gero Kramer, Jean-Christophe Eymard, Aristotelis Bamias, Joan Carles, Roberto Iacovelli, Bohuslav Melichar, ásgereur Sverrisdóttir, Christine Theodore, Susan Feyerabend, Carole Helissey, Ayse Ozatilgan, Christine Geffriaud-Ricouard, Daniel Castellano

Issue&Volume: 2019-09-30

Abstract: 

BACKGROUND
The efficacy and safety of cabazitaxel, as compared with an androgen-signaling–targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who were previously treated with docetaxel and had progression within 12 months while receiving the alternative inhibitor (abiraterone or enzalutamide) are unclear.

METHODS
We randomly assigned, in a 1:1 ratio, patients who had previously received docetaxel and an androgen-signaling–targeted inhibitor (abiraterone or enzalutamide) to receive cabazitaxel (at a dose of 25 mg per square meter of body-surface area intravenously every 3 weeks, plus prednisone daily and granulocyte colony-stimulating factor) or the other androgen-signaling–targeted inhibitor (either 1000 mg of abiraterone plus prednisone daily or 160 mg of enzalutamide daily). The primary end point was imaging-based progression-free survival. Secondary end points of survival, response, and safety were assessed.

RESULTS
A total of 255 patients underwent randomization. After a median follow-up of 9.2 months, imaging-based progression or death was reported in 95 of 129 patients (73.6%) in the cabazitaxel group, as compared with 101 of 126 patients (80.2%) in the group that received an androgen-signaling–targeted inhibitor (hazard ratio, 0.54; 95% confidence interval [CI], 0.40 to 0.73; P<0.001). The median imaging-based progression-free survival was 8.0 months with cabazitaxel and 3.7 months with the androgen-signaling–targeted inhibitor. The median overall survival was 13.6 months with cabazitaxel and 11.0 months with the androgen-signaling–targeted inhibitor (hazard ratio for death, 0.64; 95% CI, 0.46 to 0.89; P=0.008). The median progression-free survival was 4.4 months with cabazitaxel and 2.7 months with an androgen-signaling–targeted inhibitor (hazard ratio for progression or death, 0.52; 95% CI, 0.40 to 0.68; P<0.001), a prostate-specific antigen response occurred in 35.7% and 13.5% of the patients, respectively (P<0.001), and tumor response was noted in 36.5% and 11.5% (P=0.004). Adverse events of grade 3 or higher occurred in 56.3% of patients receiving cabazitaxel and in 52.4% of those receiving an androgen-signaling–targeted inhibitor. No new safety signals were observed.

CONCLUSIONS
Cabazitaxel significantly improved a number of clinical outcomes, as compared with the androgen-signaling–targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who had been previously treated with docetaxel and the alternative androgen-signaling–targeted agent (abiraterone or enzalutamide). 

DOI: 10.1056/NEJMoa1911206

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1911206

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home